Oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products for the United States
Provides direct oversight and coordination for US based strategists
Directs a cross functional team to ensure that regional requirements and expectations are achieved in an optimal and compliant manner
Serves as US and/or global product registration leader for US products, influencing cross functional development teams and governance
Oversees assembly and creation of documentation to support investigational and marketing registration packages for the US FDA
Liaises with FDA as needed for all aspects pertaining to drug development, approval, and post-approval activities
Provides high-level RA advice and identifies regulatory requirements for clinical studies and marketing approval in US
Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings
Assesses scientific data for registration purposed against regulatory requirements
Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs
Trains, develops, and manages an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion Compliance & Scientific Messaging, and International regulatory)

Requirements

Accredited bachelor’s degree
10+ years R&D experience within a pharmaceutical and/or biotech industry
7+ years’ experience in Regulatory Affairs
Experience with supporting both small molecule and biological products and ensuring regulatory compliance
Regulatory management experience (direct or indirect)
Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions
Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams
Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies
Demonstrated record of investigational and marketing application compliant management and approvals
Proven ability to navigate complex compliance and regulatory strategies
Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective
Provider of contingencies and alternate approaches to cross functional leadership and alliances
Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems
Ability to influence regulatory agency management at all levels to support regulatory needs
Highly proficient in communicating strategic and tactical issues to cross functional management
Effectively able to multi-task within assigned deadlines
Excellent written and oral communication skills

Benefits

flexible paid time off (PTO)
health benefits to include Medical, Dental and Vision
company match 401k
eligibility for a 25% bonus target based on company and individual performance
eligibility to participate in the company’s long-term incentive plan

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

regulatory strategiesdrug developmentbiological productsregulatory complianceFDA interactionsinvestigational application managementmarketing application managementscientific data assessmentcross-functional team leadershipregulatory management

Soft skills

team leadershipcommunication skillsproblem-solvinginfluencing skillsmulti-taskingmotivation of staffstrategic thinkingcreativityresourcefulnesscollaboration

Certifications

accredited bachelor’s degree